This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the xact carotid stent system. The xact carotid stent system, used in conjunction with the abbott vascular devices embolic protection system, is indicated for the improvement of the lumen diameter of carotid arteries in patients considered at high risk for adverse events from carotid endarterectomy who require percutaneous carotid angioplasty and stenting for occlusive artery disease and meet the criteria outlined as follows: 1) patients with carotid artery stenosis (>= 50% for symptomatic patients by ultrasound or angiography or >= 80% for asymptomatic patients by ultrasound or angiography), located between the origin of the common carotid artery and the intra-cranial segment of the internal carotid artery; and 2) patients must have a reference vessel diameter ranging between 4. 8 mm and 9. 1 mm at the target lesion
| Device | XACT CAROTID STENT SYSTEM |
| Classification Name | Stent, Carotid |
| Generic Name | Stent, Carotid |
| Applicant | ABBOTT VASCULAR INC. |
| Date Received | 2004-09-03 |
| Decision Date | 2005-09-06 |
| Notice Date | 2005-09-23 |
| PMA | P040038 |
| Supplement | S |
| Product Code | NIM |
| Docket Number | 05M-0381 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ABBOTT VASCULAR INC. 3200 Lakeside Drive santa Clara, CA 95054 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P040038 | Original Filing | |
| S041 | 2022-11-21 | 135 Review Track For 30-day Notice |
| S040 | 2022-06-14 | 30-day Notice |
| S039 | 2021-11-12 | 30-day Notice |
| S038 | 2021-10-29 | 30-day Notice |
| S037 | ||
| S036 | 2020-08-06 | 30-day Notice |
| S035 | 2019-02-08 | 30-day Notice |
| S034 | 2019-01-24 | 30-day Notice |
| S033 | 2018-09-05 | 30-day Notice |
| S032 | 2017-09-28 | 135 Review Track For 30-day Notice |
| S031 | 2016-05-09 | Normal 180 Day Track No User Fee |
| S030 | 2013-09-30 | 30-day Notice |
| S029 | 2013-05-14 | 30-day Notice |
| S028 | 2012-12-19 | 30-day Notice |
| S027 | 2012-06-13 | 30-day Notice |
| S026 | 2012-06-11 | 30-day Notice |
| S025 | 2012-05-24 | 30-day Notice |
| S024 | 2012-02-27 | Normal 180 Day Track No User Fee |
| S023 | 2011-08-03 | 30-day Notice |
| S022 | 2011-08-02 | 30-day Notice |
| S021 | 2011-02-28 | 30-day Notice |
| S020 | 2009-10-21 | 30-day Notice |
| S019 | 2009-05-26 | Normal 180 Day Track No User Fee |
| S018 | 2009-02-13 | Normal 180 Day Track No User Fee |
| S017 | 2009-02-11 | 30-day Notice |
| S016 | 2009-02-09 | Real-time Process |
| S015 | 2008-12-15 | Normal 180 Day Track No User Fee |
| S014 | 2008-07-10 | 135 Review Track For 30-day Notice |
| S013 | 2008-06-09 | 135 Review Track For 30-day Notice |
| S012 | 2007-12-18 | Normal 180 Day Track No User Fee |
| S011 | ||
| S010 | 2007-03-02 | 30-day Notice |
| S009 | 2006-12-26 | 30-day Notice |
| S008 | 2006-12-18 | Real-time Process |
| S007 | 2006-11-13 | Normal 180 Day Track No User Fee |
| S006 | 2006-07-10 | 135 Review Track For 30-day Notice |
| S005 | ||
| S004 | 2006-06-22 | Special (immediate Track) |
| S003 | 2006-07-14 | 135 Review Track For 30-day Notice |
| S002 | 2006-06-19 | 30-day Notice |
| S001 | 2005-09-29 | Normal 180 Day Track No User Fee |